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Nonsteroidal Anti-inflammatory Drug

Aspirin Dosing for Obesity

Phase 4

Waitlist Available

Led By Sean Heffron, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 40 and 70 years

Be older than 18 years old

Must not have

Prior gastric or bariatric surgery

Chronic inflammatory or connective tissue disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial looks at the effects of aspirin and body weight on blood and neutrophils.

Who is the study for?

This trial is for non-smoking adults aged 40-70 who are not pregnant, don't have diabetes, bleeding/clotting disorders, immune deficiencies, or chronic inflammatory diseases. They shouldn't have had recent changes in statin drugs or surgeries affecting the stomach and must not be on certain medications including aspirin.

What is being tested?

The study is testing how different doses of aspirin (81mg and 325mg) affect blood levels of substances that help resolve inflammation in obese individuals. It's a placebo-controlled study where participants will receive both doses and a placebo at different times without knowing which one they're getting.

What are the potential side effects?

Aspirin can cause side effects like stomach pain, heartburn, nausea, increased risk of bleeding. Rarely it may lead to severe allergic reactions or worsening asthma symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had stomach or weight-loss surgery in the past.

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I have a long-term inflammatory or connective tissue condition.

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I am currently taking corticosteroids.

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I am not taking drugs or supplements that affect COX-1, COX-2, or lipoxygenases.

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I have diabetes.

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I have a known bleeding or clotting disorder.

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I have a weakened immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Aspirin 81mg, Then Aspirin 325mgExperimental Treatment2 Interventions

After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.

Group II: Aspirin 325mg, Then Aspirin 81mgExperimental Treatment2 Interventions

After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin 325mg

2019

Completed Phase 2

~140

0 / 8Eligibility criteria met